A Study of of HOT1030 in Patients With Advanced Solid Tumors
2021年9月17日 更新者:Huabo Biopharm Co., Ltd.
A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HOT1030 in Patients With Advanced Solid Tumors
A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HOT-1030 in Patients with Advanced Solid Tumors
研究概览
详细说明
This study is an open-label, Phase 1, study to evaluate the safety, tolerability, PK, and PD profiles of HOT-1030 as a monotherapy to assess the maximum tolerated dose (MTD) in subjects with advanced solid tumors.
研究类型
介入性
注册 (预期的)
42
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:yang yongming, Doctor
- 电话号码:+86 18964167352
- 邮箱:yongmin.yang@huaota.com
学习地点
-
-
Shanghai
-
Shanghai、Shanghai、中国
- 招聘中
- Shanghai Huaota Biopharmaceutical Co., Ltd.
-
接触:
- Yang yongming, doctor
- 电话号码:18964167352
- 邮箱:杨永民<yongmin.yang@huaota.com>
-
首席研究员:
- Han Baohui, doctor
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female from 18 to 75 yrs (include 18 yrs and 75 yrs).
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Patients with histologically or cytologically confirmed advanced malignant solid tumor who have received or been intolerant of all standard therapies thought to confer clinical benefit.
- Measurable disease on imaging base on RECIST v1.1 for solid tumors;
- Stop anticancer therapy for more than 5 half-lives or 4 weeks (whichever is shorter) prior to study entry;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate organ function, as indicated by the laboratory values.
- Female patients of childbearing potential must have a negative serum pregnancy test at screening; Male patients and the female patients of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the Screening Visit through 90 days after the last dose of study treatment is received.
- Life expectancy >3 months.
Exclusion Criteria:
- Received any anti-CD137 antibodies.
- Active primary CNS tumor or metastatic CNS tumor (expect the patients who had received the treatment and stopped the treatment for more than 4 weeks before first dose), active epilepsy, Spinal cord compression or Cancerous meningitis.
- Active autoimmune disease or history of autoimmune disease requiring systemic therapy < 2 years prior to screening except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type I diabetes. Patients with childhood asthma or atopy that has not been active in the 2 years prior to study screening are eligible.
- Require systematic anti-infective therapy a week before first dose because of active infection.
- Taken the surgical operations not related to the research 4 weeks before first dose
Used of systemic corticosteroids (a dose equivalent > 10 mg/day of prednisone or )or other immunosuppressive agents, excepted:
- Patients are allowed to have topical use or inhaled glucocorticoid.
- Patients are allowed to have a less than seven-day glucocorticoid treatment preventing or treat non-autoimmune allergic diseases.
- The toxicity of previous anti-tumor therapy has not recovered (defined as not recovering to grade 0 or 1, except for alopecia) or has not fully recovered from previous surgery.
- During the 6 months prior to screening, the patient had a history of major cardiovascular and cerebrovascular events, such as myocardial infarction, coronary angioplasty or bypass surgery, heart valve repair, unstable arrhythmias, unstable angina, transient ischemic attack, or cerebrovascular accidents.
- New York Heart Association (NYHA) grade III or IV congestive heart failure.
- Patients with uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg at the time of screening) who had been on a stable dose of antihypertensive drugs for at least 4 weeks at the time of screening).
- Active hepatitis B (hepatitis B virus titer >103 copies /ml or 200IU/ml); Hepatitis C virus infection (HCV-RNA above the detection limit); Prophylaxis antiviral therapy other than interferon is allowed. In patients with advanced liver cancer (HCC), hepatitis B virus titer >104 copies /ml or 2000IU/ml should be excluded.
- A history of known congenital and acquired immunodeficiency, including positive HIV antibody tests.
- Patients with a known history of severe allergic reactions to macromolecular protein formulations/monoclonal antibodies or to any investigational drug component (CTCAE V5.0 grade greater than 3).
- Participated in clinical trials of other drugs within 4 weeks before the first administration.
- Pregnant or lactating women or women at risk of pregnancy have a positive pregnancy test before the first medication.
- Other investigators consider that the patient has any clinical or laboratory abnormality that makes him unsuitable for participation in this clinical study.
- prior history of a clear neurological or psychiatric disorder, including epilepsy or dementia.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Cohort 1
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
其他名称:
|
实验性的:Cohort 2
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
其他名称:
|
实验性的:Cohort 3
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
其他名称:
|
实验性的:Cohort 4
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
其他名称:
|
实验性的:Cohort 5
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
其他名称:
|
实验性的:Cohort 6
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
其他名称:
|
实验性的:Cohort 7
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety and tolerability as measured by incidence of AEs (Adverse Events)
大体时间:through study completion, an average of 1 year
|
Incidence and severity of AEs, Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
|
through study completion, an average of 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Area Under Curve (AUC) of HOT-1030
大体时间:42 days
|
Area under the concentration-time curve of HOT-1030 in plasma over the time interval from 0 extrapolated to infinity
|
42 days
|
Maximum Serum Concentration (Cmax) of HOT-1030
大体时间:42 days
|
Maximum Serum Concentration (Cmax) in plasma
|
42 days
|
Antitumor Activity of HOT-1030 in Patients With advanced Solid Tumors
大体时间:through study completion, an average of 1 year
|
Response is defined as a Complete Response + Partial Response and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
|
through study completion, an average of 1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Han Baohui, Doctor、Shanghai Chest Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年3月12日
初级完成 (预期的)
2023年6月30日
研究完成 (预期的)
2023年6月30日
研究注册日期
首次提交
2021年3月26日
首先提交符合 QC 标准的
2021年9月17日
首次发布 (实际的)
2021年9月29日
研究记录更新
最后更新发布 (实际的)
2021年9月29日
上次提交的符合 QC 标准的更新
2021年9月17日
最后验证
2021年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- HOT-1030-1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
实体瘤,成人的临床试验
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AstraZeneca招聘中Adv Solid Malig - H&N SCC、ATM Pro / Def NSCLC、胃癌、乳腺癌和卵巢癌西班牙, 美国, 比利时, 英国, 法国, 匈牙利, 加拿大, 大韩民国, 澳大利亚
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-
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Imperial College London完全的